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WARNING: The prolonged administration of procainamide often leads to the development of a positive anti-nuclear antibody (ANA) test, with or without symptoms of a lupus erythematosus-like syndrome. If a positive ANA titer develops, the benefit versus risks of continued procainamide therapy should be assessed.
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PROCAINAMIDE SUMMARY
PROCAINAMIDE HYDROCHLORIDE
Injection, USP
Procainamide Hydrochloride Injection, USP is a sterile, nonpyrogenic solution of procainamide hydrochloride in water for injection. Each milliliter of the 2 mL vial contains procainamide hydrochloride 500 mg; methylparaben 1 mg and sodium metabisulfite 1.8 mg added in water for injection. Each milliliter of the 10 mL vial contains procainamide hydrochloride 100 mg; methylparaben 1 mg and sodium metabisulfite 0.8 mg added in water for injection. In both formulations, the solution may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. pH 5.0 (4.0 to 6.0). Headspace nitrogen gassed. Procainamide Hydrochloride Injection is intended for intravenous or intramuscular administration. Procainamide hydrochloride, a Group 1A cardiac antiarrhythmic drug, is ρ-amino-N-[2-(diethylamino) ethyl] benzamide mono-hydrochloride.
Procainamide hydrochloride injection is indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgement of the physician, are life-threatening. Because of the proarrhythmic effects of procainamide, its use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided.
Initiation of procainamide treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital.
Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias.
Because procainamide has the potential to produce serious hematological disorders (0.5 percent) particularly leukopenia or agranulocytosis (sometimes fatal), its use should be reserved for patients in whom, in the opinion of the physician, the benefits of treatment clearly outweigh the risks. (see WARNINGS and Boxed Warning.)
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NEWS HIGHLIGHTS
Published Studies Related to Procainamide
Levofloxacin and ciprofloxacin decrease procainamide and N-acetylprocainamide renal clearances. [2005.04]
Ten healthy adults participated in a randomized, crossover drug interaction study testing procainamide only, procainamide plus levofloxacin, and procainamide plus ciprofloxacin.
Clinical Trials Related to Procainamide
Iv Amiodarone Versus Iv Procainamide to Treat Haemodynamically Well Tolerated Ventricular Tachycardia [Recruiting]
The purpose of this study is to determine whether intravenous amiodarone has less cardiac
significant adverse events compared to intravenous procainamide in the acute treatment of
haemodynamically well tolerated wide QRS tachycardia, the majority of them of probably
ventricular origen.
Certain People With A Fib May Have Changes on Ecg When Given Procainamide That May be Related to a Genetic Difference [Recruiting]
The purpose of this study is to look for a similarity in people's genes that may help
understand which people could benefit from certain drugs for the treatment of atrial
fibrillation.
Ajmaline Utilization in the Diagnosis and Treatment of Cardiac Arrhythmias [Recruiting]
The study evaluates 3 different populations:
It is an open, randomized, parallel-group study comparing the effectiveness of intravenous
(iv) ajmaline with currently used antiarrhythmic drugs in the acute treatment of :
1. recent-onset atrial fibrillation versus iv flecainide
2. sustained monomorphous ventricular tachycardia versus iv procainamide
The study also evaluates in an open, randomized, crossover study, the use of iv ajmaline
versus iv flecainide in the diagnosis of Brugada syndrome
Cardiac Arrest in Seattle: Conventional Versus Amiodarone Drug Evaluation (CASCADE) [Completed]
To compare the efficacy of amiodarone to conventional anti-arrhythmic therapy in individuals
who had survived one episode of out-of-hospital cardiac arrest.
Electrophysiologic Study Versus Electrocardiographic Monitoring (ESVEM) [Completed]
To determine whether electrophysiologic study (EPS) or Holter monitoring (HM) was the better
method for selecting effective long-term antiarrhythmic drug therapy in patients with
sustained ventricular tachycardia, ventricular fibrillation, or an episode of aborted sudden
death.
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Page last updated: 2006-01-31
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